CapnoSpot Pneumothorax Decompression Indicator
K-Number: K223625 · 2023-03-28
ApplicantPneumeric, Inc.
Decision Date2023-03-28
Product CodeGAA
Advisory CommitteeSU
DecisionSubstantially Equivalent
Device Summary
CapnoSpot Pneumothorax Decompression Indicator is a medical device manufactured by Pneumeric, Inc.. It received FDA 510(k) clearance on 2023-03-28 under approval number K223625. The device is classified under product code GAA. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the CapnoSpot Pneumothorax Decompression Indicator?
CapnoSpot Pneumothorax Decompression Indicator is a medical device that received FDA 510(k) clearance on 2023-03-28. It is manufactured by Pneumeric, Inc.. The 510(k) number is K223625.
When was CapnoSpot Pneumothorax Decompression Indicator approved by the FDA?
CapnoSpot Pneumothorax Decompression Indicator received FDA 510(k) clearance on 2023-03-28, under approval number K223625.
What company makes CapnoSpot Pneumothorax Decompression Indicator?
CapnoSpot Pneumothorax Decompression Indicator is manufactured by Pneumeric, Inc..
What is the FDA product code for CapnoSpot Pneumothorax Decompression Indicator?
The FDA product code for CapnoSpot Pneumothorax Decompression Indicator is GAA.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.